Virtual Reality for Appendectomy Pain

February 6, 2023 updated by: Children's Hospital Medical Center, Cincinnati

Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy

To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 8 - 18 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix

Exclusion Criteria:

  • Outside of age range (<8 or >18 years)
  • History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
  • History of vertigo, dizziness, and/or seizure disorders
  • Conditions that would preclude the application of the VR headset, such as craniofacial deformities
  • History of chronic pain, frequent opioid use and/or active cancer therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: VR-Biofeedback
Other: VR-Biofeedback
Participants will be instructed to use the Mindful Aurora Application
OTHER: VR-Distraction
Other: VR-Distraction
Participants will be instructed to use one of four applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of VR-biofeedback on pain
Time Frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Postoperatively 24 - 90 hours.
Effect of VR-distraction on pain
Time Frame: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Postoperatively 24 - 90 hours.
Effect on VR-biofeedback on anxiety
Time Frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Before 10 minute VR session.
Effect on VR-biofeedback on anxiety
Time Frame: Immediately after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Immediately after VR session.
Effect on VR-biofeedback on anxiety
Time Frame: 15 minutes after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
15 minutes after VR session.
Effect on VR-biofeedback on anxiety
Time Frame: 30 minutes after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
30 minutes after VR session.
Effect of VR-biofeedback on medication use
Time Frame: 24-90 hours
Amount of pain medications used will be collected
24-90 hours
Effect of VR-distraction on anxiety
Time Frame: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Before 10 minute VR session.
Effect of VR-distraction on anxiety
Time Frame: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Immediately after 10 minute VR session.
Effect of VR-distraction on anxiety
Time Frame: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
15 minutes after 10 minute VR session.
Effect of VR-distraction on anxiety
Time Frame: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
30 minutes after 10 minute VR session.
Effect of VR-distraction on medication use
Time Frame: 24-90 hours
Pain medications used will be collected
24-90 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of anxiety on changes in pain
Time Frame: One time prior to study visit
Participants will complete a questionnaire regarding anxiety
One time prior to study visit
Role of pain catastrophizing
Time Frame: One time prior to study visit
Participants will complete a questionnaire regarding pain
One time prior to study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Vanessa Olbrecht, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2020

Primary Completion (ACTUAL)

August 30, 2021

Study Completion (ACTUAL)

August 30, 2021

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (ACTUAL)

April 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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